Roche received complaints from customers reporting the generation of false mutation detected results for the exon 20 insertion (ex20ins) mutation when using the cobas® egfr mutation test v2.During in-house testing using customer-provided ffpet samples, an ex20ins false mutation detected result was reproduced for one out of 8 ffpet samples, which was processed following the validated sample preparation method from the instructions for use.Although the majority of cases reported were from users using ffpet samples, the generation of false mutation detected ex20ins results with plasma specimens was reported in one case.A false mutation detected ex20ins result could lead to harm under specific scenarios.Consignees were notified of the issue with instruction to follow the instructions for use for sample input requirements.Additionally, if an ex20ins mutation detected result is generated with the cobas® egfr mutation test v2, customers must confirm the result with another method (e.G., sequencing or other pcr-based tests).(b)(4).
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A customer in (b)(6) alleged the generation of a false exon20 insertion mutation result for a patient tested with the cobas® egfr mutation test v2.Upon repeat testing with other platforms (oncomine and amoy), no exon20 insertion mutation was detected.The patient tried to enter a tki clinical trial since the cobas egfr test generated an exon20 insertion mutation detected result.However, the test results using oncomine and amoy were negative for ex20ins, so the patient did not enter the trial.No harm or injury was indicated.
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